Kornimate/medical-research-clean huggingface dataset:
laser therapy in preventing oral mucositis in patients undergoing bone marrow transplantation

Conditions: Oral Complications

Summary: rationale: laser therapy may reduce the severity of symptoms and speed healing of oral mucositis. it is not yet known if laser therapy is effective in preventing oral mucositis. purpose: randomized phase ii/iii trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation.

objectives: i. determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation. outline: this is a randomized, double-blind, placebo-controlled study. patients are randomized to one of three treatment arms. arm i: patients undergo low-energy laser therapy with visible red light (650 nm) daily over 15-20 minutes beginning on the first day of their transplant conditioning regimen and continuing until day 2 after bone marrow transplantation. arm ii: patients undergo low-energy laser therapy with invisible infra-red light (780 nm) daily on the same schedule as in arm i. arm iii: patients undergo sham laser therapy daily on the same schedule as in arm i. patients are followed on days 3, 7, 10, 14, 18, 21, and 24. projected accrual: a total of 66 patients (22 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: at risk of developing oral mucositis due to toxicity resulting from one of the following: preparative chemoradiotherapy multiple drug conditioning regimens graft-versus-host disease (gvhd) prophylaxis patient characteristics: age: over 12 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: able to carry out routine oral care no active oral, viral, bacterial, or fungal infections no active uncontrolled oral bleeding that would preclude laser therapy prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: not currently enrolled on other protocols with oral mucositis as a stated end point (e.g., conditioning regimen toxicity trials or gvhd prophylaxis trials) no other concurrent investigational drugs or agents for the prevention or treatment of mucositis no concurrent photosensitizing agents

Keywords: oral complications
effects on experimental dyspnea of high flow nasal cannula

Conditions: Dyspnea; Healthy Volunteers

Summary: to develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (hfnc).

this study will measure the effect of hfnc on an experimental model of dyspnea induced by thoraco-abdominal elastic strapping on healthy subjects at rest. the study will also compare the effects on dyspnea of the administration of high flow nasal cannula with and without oxygen added.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * chronic pathology * active smokers * anxiety disorder * allergy to latex * protected adult * woman declared herself pregnant

Keywords: dyspnea, high flow nasal cannula
intravitreal ozurdex after pars plana vitrectomy for proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: to evaluate if intravitreal ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (ppv) in patients with proliferative diabetic retinopathy (pdrp).

to perform a randomized, controlled, study on patients that undergo ppv for vitreous hemorrhage secondary to pdrp. half of the patients will receive an intravitreal ozurdex implant immediately after surgery. the primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second ppv. secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Eligibility criteria:
inclusion criteria: * patients with vitreous hemorrhage undergoing ppv for pdrp exclusion criteria: * previous ppv * vitreous hemorrhage of non-pdrp origin

Keywords: pdrp vitreous hemorrhage vitrectomy
single dose amikacin for uncomplicated cystitis in the ed: a feasibility study

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to determine if a single dose of amikacin (a type of antibiotic) can be used to effectively treat emergency department patients with uncomplicated cystitis (inflammation of the bladder). participating in this study will allow the patient to treat their urinary tract infection (uti) with a single intramuscular (im (into the arm)) or intravenous (iv (into the vein)) shot of amikacin, rather than having to go to the pharmacy to pick up a prescription for antibiotics, and then take antibiotics for 3-7 days. a single dose of amikacin has been demonstrated to be safe, effective and well tolerated in other studies, but some patients may decline to participate because they do not wish to have an iv or im shot, or because they don't want to speak on the phone with a research assistant three times over the next 30 days.

he study is a prospective open-label cohort study that seeks to enroll 75 ed patients diagnosed with uncomplicated cystitis. enrolled patients will be treated with a single dose of amikacin. the primary endpoint is clinical cure at 3 days. we chose a non-comparative design as our treatment strategy is literature- and guideline- supported; our goal is demonstrate that it is feasible to execute this approach out of the emergency department. urine culture is not recommended in the in the initial management of patients with uncomplicated uti treated in emergency or primary care settings.3 data collection procedures: patients will be enrolled as a convenience sample by the research team. the investigators will determine eligibility, approach the ed clinical team, then approach and consent the patient. if consented, patient will be treated with amikacin 15 mg/kg iv or im, based on actual body weight; for patients \>120% of ibw, we will use adjbw (ibw + 0.4(abw-ibw)) rounded to nearest 50 mg. patients who already have an iv will receive the medication iv, otherwise the dose will be given im. the study measurements at enrollment are age, pmh, meds, allergies, symptoms, and symptom duration as well as urinalysis results, amikacin dose and route. telephone follow-up at 3, 7, and 30 days will include the following data points: symptom resolution: (complete resolution / mostly better / a little better / same / worse); any new symptoms; any provider visits since index visit (if any visits, describe).

Eligibility criteria:
inclusion criteria: * female emergency medicine patients * ≥14 years of age * uncomplicated urinary tract infection * a primary urinary complaint and nitrite-positive urine. exclusion criteria: * pregnancy * abnormal genitourinary tract * recent urinary tract instrumentation * immunosuppression * crcl \< 25 ml/min * evidence of pyelonephritis or sepsis * any antibiotic treatment within 30 days * not available for phone follow-up in 3, 7, and 30 days * requires admission to the hospital * abnormal mental status.

Keywords: urinary tract infections amikacin emergency medicine
stellar-rosuvastatin vs. atorvastatin, pravastatin, simvastatin across dose ranges

Conditions: Hypercholesterolemia

Summary: to compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.


Eligibility criteria:
inclusion criteria: * discontinuation of all previous lipid lowering therapy. * fasting ldl-c levels of between 160mg/dl - 250 mg/dl at visits 2 \& 3 for subjects not on lipid lowering therapy at visit 1. * other lipid parameters as specified in the protocol. exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1. * active arterial disease eg unstable angina, or recent arterial surgery * abnormal laboratory parameters as defined in the protocol.

Keywords: cholesterol hypercholesterolemia low density lipoproteins
onset of action of advair hydrofluoroalkane (hfa) 115/21 in comparison to symbicort pressurised metered-dose inhalers (pmdi) 160/4.5 measured by impulse oscillometry (ios)

Conditions: Asthma

Summary: the objectives of this study are to measure impulse oscillometry (ios) in patients with asthma extensively at baseline in patients with mild-to-moderate asthma, treated with as-needed short acting beta agonist only, to measure respiratory resistance and small airway dysfunction accurately and precisely at baseline, from which to measure onset of action of advair mdi in comparison with that of symbicort mdi. initial screening will assess ios resistance and small airway dysfunction and its response to short acting beta agonist (saba). patients will be selected from among those who manifest a 40% improvement in small airway function assessed by ios low frequency reactance after saba compared to baseline. after screening, patients will be randomized to receive either advair or symbicort; and will be assessed at randomization before and at several intervals after initial dosing, up to 4 hours. patients will return again 4 weeks after randomization for extended ios (and spirometry) testing as done at randomization.

eligibility criteria include age 12-45 years, with current treatment of asthma with as-needed saba only; and manifesting an acute response to saba at screening of 40% or greater improvement in ios low frequency reactance. after inclusion in the protocol, all subjects will receive active treatment, either with advair or with symbicort. outcome measures will include large and small airway resistance and integrated low-frequency reactance calculated directly from ios measures, and in addition, large airway resistance, small airway resistance and small airway compliance derived from an electrical equivalent respiratory system model. analysis of ios data will be done post-testing by a respiratory physiologist, experienced with use of ios and its analysis and interpretation, blinded to which treatment each individual received. electrical-equivalent respiratory system model analyses will be done by a biomedical engineer, blinded to which treatment each individual received.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * asthma symptoms controlled by short-acting beta agonist as-needed * age 12-45 years exclusion criteria: * severe asthma * use of oral or inhaled corticosteroids within 30 days of screening

Keywords: asthma forced oscillation impulse oscillometry electrical-equivalent respiratory system model
optical nerve sheath changes during head down laparoscopy

Conditions: Intracranial Hypertension; Brain Edema; Pneumoperitoneum; Surgery, Laparoscopic

Summary: patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema. ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. it is unknown how optical nerve sheath diameter changes after prolonged head down position.


Eligibility criteria:
inclusion criteria: * patients undergoing elective laparoscopic prostatectomy in steep trendelenburg position * american society of anesthesiologists risk i-iii exclusion criteria: * age \ 70 years * american society of anesthesiologists risk \>iii * assumption of beta-2-blockers, diuretics * heart failure with nyha class ≥ iib * diabetes with ocular (i.e. retinopathy), neurologic (i.e. peripheral neuropathy), or renal complications * history of cardiac surgery, thoracic surgery, suprainguinal vascular surgery, head surgery, ocular surgery, stroke, hydrocephalus.
arthroscopic assisted balloon tibioplasty for the treatment of schatzker ii-iv tibial plateau fractures

Conditions: Arthroscopy; Tibial Fractures; Orthopedic; Fracture Fixation

Summary: the investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

the balloon tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.the investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * fresh closed fracture x-ray and ct examination confirmed schatzker ii-iv type tibial plateau fracture patients. * the patient signed the informed consent. exclusion criteria: * pathologic fractures, patients with neurologic disorders, and skeletally immature patients.
in vivo dosimetry during prostate cancer radiotherapy

Conditions: Prostate Disease

Summary: the goal of this clinical research study is to learn if a rectal balloon with attached radiation detectors can be used to help researchers monitor the dose of external beam radiation that is delivered to the prostate during treatment. this may help researchers better understand the side effects of radiation therapy, such as rectal bleeding, and may lead to changes in treatment planning or treatment delivery.

as a part of your standard of care, you will have external beam radiation therapy. you will have a computerized tomography (ct) scan of the pelvis before the external beam radiation therapy. for the ct scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder a rectal balloon will then be inserted into your rectum and filled with either air or water. you will then have the ct scan. the ct scan should take about 45 minutes. if you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two ct scans per week you will have while you are receiving radiation. you may have additional ct scans (without the detector) each week if your doctor thinks it is needed. the doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study. you will be off study after your final radiation treatment using the rectal balloon. this is an investigational study. up to 15 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients. 2. the selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study. 3. we will choose patients undergoing photon and proton treatments. exclusion criteria: n/a

Keywords: fiber optic radiation detectors enhanced endorectal balloon radiation treatment radiotherapy external beam radiation dosimetry
predictive value of sofa and apache scores for in-hospital mortality in covid-19 icu patients

Conditions: Covid19

Summary: the aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the sofa and apache scores in a covid-19 icu cohort and to develop a new prediction model for covid-19 patients admitted to the icu from 13th of march 2020 until 17th of october 2020.

the coronavirus disease (covid-19), caused by the severe acute respiratory syndrome coronavirus 2 (sars cov-2) emerged in december 2019 and has rapidly spread worldwide. the mortality of critical ill patients with covid-19 has been reported variously as low as 11% and as high as 61%. the application of scoring systems can facilitate the effective evaluation by physicians to screen severe patients. at present, however, there are no specific scoring systems for the evaluation of covid-19 patients. scoring systems such as the sequential organ failure assessment (sofa) score can help emergency or critical care physicians for prognosis and predicting mortality. the sofa score described the condition of multiple organ dysfunction through several parameters, including oxygenation index, mean arterial pressure, glasgow come scale, creatinine or urine volume, bilirubin, platelets for the respiratory, circulatory, neurological, renal, hepatogenic and coagulation systems respectively. the function of each organ system is scored from 0 to 4, and the individual sofa scores are summed to a total score. although sofa was not initially designed to predict mortality, several studies reveal that sofa could predict morbidity and mortality in severe ill patients. besides the sofa score, the acute physiology and chronic health evaluation (apache ii) scores was designed to measure the severity of disease of patients admitted to the icu and to predict mortality. the apache ii score is calculated based on physiological measurements such as body temperature, mean arterial pressure, ph, heart and respiratory rate, glasgow coma scale, oxygenation and blood parameters such as sodium, potassium, creatinine, hematocrit and white blood cell count. recently, the apache iv score is developed where additional parameters such as admission information, admission diagnosis and chronic health conditions were take into account.

Eligibility criteria:
inclusion criteria: * covid-19 patients admitted to the icu from 13th of march 2020 until 17th october 2020. exclusion criteria: -
g5® mobile continuous glucose monitoring system automated vs. manual sensor applicator

Conditions: Diabetes Mellitus

Summary: comparison of g5® mobile continuous glucose monitoring system accuracy when using an automated applicator vs. a manual sensor applicator

the objective of the study is to demonstrate the performance, i.e. efficacy of the g5x system with the automated applicator is no worse than that of the commercial dexcom g4 tm platinum continuous glucose monitoring system (g4 system) with the manual applicator.

Eligibility criteria:
inclusion criteria: * ages 2 or older * diagnosis of type 1 diabetes or type 2 diabetes * willing to participate in a clinic session involving venous sampling for evaluation of study end point exclusion criteria: * use of acetaminophen * known allergy to medical-grade adhesives * pregnancy * hematocrit outside specification of the study-assigned blood glucose meter

Keywords: endocrine system diseases glucose metabolism disorders metabolic diseases
the role of intestinal and vaginal microbiota, estrogenic activity, metabolic profile & nutritional status in endometriosis

Conditions: Endometriosis

Summary: endometriosis (ems) is one of the most prevalent benign gynaecological diseases, and it is an inflammatory oestrogen-dependent condition. several authors have proposed that anatomical, genetic, endocrine, immunological, environmental, hormonal, and inflammatory factors may influence tissue implantation outside the uterus. an approach to ems aetiology that involves defining a profile to the vaginal and gut microbiota, estrogenic activity, and exposure to xenoestrogens and also metabolic and nutritional status of women with ems may help identify some important patterns to better characterize this disease and also to define more personalized nutritional strategies, also predicting patients' predisposition to therapy success. this is an observational study on premenopausal woman, diagnosed with ems, who will be recruited on the outpatient gynaecology appointment, to evaluate the vaginal and intestinal microbiome, measure the total estrogenic activity, assess the metabolic biomarkers and the nutritional status.


Eligibility criteria:
inclusion criteria: * premenopause; * diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted); * bmi between 18.5 and 30.0 kg/m2 exclusion criteria: * postmenopause; * vegetarian diet; * pregnancy or breastfeeding; * continuous hormonal therapy for endometriosis; * laparoscopic surgery for endometriosis purpose; * gastrointestinal or vaginal infections; * intaken antibiotics and/or probiotics within the last 8 weeks; * medications to treat vaginal infections in the past 3 months.

Keywords: endometriosis gut microbiota vaginal microbiota estrogenic activity xenoestrogens metabolic biomarkers nutritional status